2025-04-11
Meiji BioPharma has received FDA approval for its IND application for an oral paclitaxel soft capsule with “zero defects.” This marks the world’s first and only oral paclitaxel soft capsule project to receive clinical trial approval.
Medicilon as a long-term partner of Meiji BioPharma, provided comprehensive preclinical R&D services, including formulation development, pharmacodynamics, pharmacokinetics, and safety evaluation. The collaboration not only demonstrated the strengths of both parties in innovation but also successfully overcame several technical challenges.
Paclitaxel Innovative Breakthrough: Oral Formulation Revolution and Superior Efficacy
Paclitaxel, a renowned anti-cancer drug, has traditionally been limited to intravenous administration due to its poor water solubility and low bioavailability. This has caused significant side effects and inconvenience for patients. Meiji BioPharma leveraging its poorly soluble drug delivery platform, successfully developed an oral paclitaxel soft capsule that inhibits tumor-overexpressed P-glycoprotein.
Preclinical studies showed:
- Superior Efficacy Profile: Demonstrated non-inferiority/superiority versus Abraxane and Taxol; with comparable or better performance than lenvatinib and sorafenib in liver cancer models. Achieved near-complete tumor inhibition (≈100%) with 3-6 fold tumor volume reduction after three-week treatment cycles.
- Enhanced Safety & Dosing Flexibility: Linear dose-AUC (0-t) relationship enables predictable pharmacokinetics. Favorable safety profile supports both monotherapy and combination regimens with PD-1/PD-L1 and VEGF inhibitors, potentially reducing treatment costs and improving patient outcomes.
Medicilon’s One-Stop R&D Services: Helping Overcome the “Impossible” Challenge
- Formulation Development: The innovative soft capsule formulation improved oral bioavailability. Medicilon’s formulation team developed a soft capsule that forms a uniform emulsion in the gastrointestinal tract, enhancing paclitaxel’s solubility and stability.
- Pharmacodynamic Evaluation: Medicilon’s team developed a precise method for administering the capsule contents to mice, ensuring reliable preclinical data. They also expanded research into liver and stomach cancer using over 440 tumor models.
- Integrated R&D Strategy: Medicilon’s platform integrated expertise from formulation, pharmacodynamics, pharmacokinetics, and toxicology to design a comprehensive development strategy. By the end of 2024, Medicilon had provided full IND application services for 69 projects.
With the FDA approval and the initiation of NMPA application, the oral paclitaxel soft capsule is expected to offer a better treatment option for global cancer patients. Medicilon looks forward to the successful progress of the clinical trials and continued innovation to empower partners in overcoming R&D bottlenecks and accelerating the global reach of Chinese innovative drugs.
